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Safety And Tolerability Of Subcutaneous MANP In Difficult To Control/Resistant Hypertensive Subjects — DTC/RHS  

Resistant Hypertension Clinical Trial

Official title:
A Phase 1B, Multiple Ascending Dose Trial Examining The Safety And Tolerability Of Subcutaneous MANP In Difficult To Control/Resistant Hypertensive Subjects

Clinical Trial Summary

A randomized, double-blind, placebo-controlled multiple ascending dose study in hypertensive subjects on stable doses of at least three hypertensive drugs for at least 6 weeks prior to Screening. The study will consist of screening, PK-unit admittance, and safety follow up periods. Subjects will be randomized at a 6:2 ratio of either MANP or placebo and will be stratified by race in each dosage cohort. The entire first Cohort will be given the lowest dosage with subsequent cohorts progressing sequentially to the higher doses depending on safety and tolerability of the previous cohort. Endpoints not related to the safety reviews will be analyzed after the last patient last visit (LPLV).

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05247528
Study type Interventional
Source E-Star BioTech, LLC
Contact
Status Completed
Phase Phase 1
Start date December 20, 2021
Completion date October 31, 2022
View Details
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